UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044222
Receipt number R000050122
Scientific Title The Effect of mastication on periodontal disease and oral function
Date of disclosure of the study information 2021/06/01
Last modified on 2022/06/15 10:16:23

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Basic information

Public title

The Effect of mastication on periodontal disease and oral function

Acronym

The Effect of mastication on periodontal disease and oral function

Scientific Title

The Effect of mastication on periodontal disease and oral function

Scientific Title:Acronym

The Effect of mastication on periodontal disease and oral function

Region

Japan


Condition

Condition

periodontal disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of treatment for periodontal disease and training of chewing on periodontal disease and oral function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

an outcome related to evaluation for periodontal disease

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

treatment for periodontal disease combined with training of chewing

Interventions/Control_2

treatment for periodontal disease

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

need for treatment for periodontal disease and low masticatory performance

Key exclusion criteria

remaining teeth <20; posterior occlusal pairs <5; use for removable partial denture; need for periodontal surgery; having smoking a habit; any problem of temporomandibular joint; xerostomia; any problem of stomatognathic system; any of mental disease; receiving diet restriction; can not control contents of meal

Target sample size

58


Research contact person

Name of lead principal investigator

1st name Yuriko
Middle name
Last name Komagamine

Organization

Tokyo Medical and Dental University

Division name

Gerodontology and Oral Rehabilitation

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-4645

Email

y.komagamine.gerd@tmd.ac.jp


Public contact

Name of contact person

1st name Yuriko
Middle name
Last name Komagamine

Organization

Tokyo Medical and Dental University

Division name

Gerodontology and Oral Rehabilitation

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-4645

Homepage URL


Email

y.komagamine.gerd@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Lotte Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-5404

Email

rec.adm@tmd.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2021 Year 06 Month 30 Day

Date of IRB

2021 Year 06 Month 11 Day

Anticipated trial start date

2021 Year 07 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 16 Day

Last modified on

2022 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050122


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name